药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/10/29 – 2024/11/04

Period
2024/10/29 to 2024/11/04, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
344
Drugs with new generic filings (by drug name, de-duplicated)
68
Accepted this week, now under review
3

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Drug and company names link to detail pages; sign in to view them.

New acceptances this week

By application type and drug type

344filings, 94 of them generic

By application type

Application typeFilings
Supplement172
Generic94
New drug52
Import12
Unspecified11
Import re-registration3

By drug type

Drug typeFilings
Chemical drug213
TCM85
治疗用生物制品34
Biologic6
预防用生物制品6

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

68 drugs with new generic filings; top 10 listed

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

208 companies with new acceptances; top 10 listed

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

102 this week

AcceptedDrugApplicants
2024/11/04New drug · Class 1.3 ZY022胶囊CXZL2400076 中国医学科学院药物研究所; 湖南省天玑珍稀中药材发展有限公司
2024/11/04New drug · Class 1.3 ZY022CXZL2400075 中国医学科学院药物研究所; 湖南省天玑珍稀中药材发展有限公司
2024/11/02Generic · Class 3 间苯三酚口崩片CYHS2403744 南京海纳制药有限公司
2024/11/02Generic · Class 3 恩格列净二甲双胍缓释片CYHS2403743 南京易亨制药有限公司
2024/11/02Generic · Class 3 多索茶碱片CYHS2403742 浙江花园药业有限公司
2024/11/02Generic · Class 3 多索茶碱片CYHS2403741 浙江花园药业有限公司
2024/11/02Generic · Class 3 盐酸甲氧氯普胺注射液CYHS2403734 平光制药股份有限公司
2024/11/02Generic · Class 3 盐酸溴己新口服溶液CYHS2403730 江苏开元药业有限公司; 江苏欧歌制药有限公司
2024/11/02New drug · Class 3.3 流感病毒裂解疫苗CXSS2400118 安徽智飞龙科马生物制药有限公司
2024/11/02New drug · Class 1 注射用HLX43CXSL2400747 上海复宏汉霖生物技术股份有限公司; 上海复宏汉霖生物医药有限公司
2024/11/02New drug · Class 1 SYHA1813口服溶液CXHL2401166 上海润石医药科技有限公司
2024/11/02New drug · Class 1 SYHA1813口服溶液CXHL2401165 上海润石医药科技有限公司
2024/11/02New drug · Class 1 SYHA1813口服溶液CXHL2401164 上海润石医药科技有限公司
2024/11/02New drug · Class 2.3 HQ2303CXHL2401163 百诚医药(珠海横琴)有限公司
2024/11/02New drug · Class 1 注射用MB0151CXHL2401162 主流源生物科技(上海)有限公司; 中山主流源生物科技有限公司
2024/11/02New drug · Class 2.1;2.4 盐酸(R)-氯胺酮注射液CXHL2401161 江苏豪森药业集团有限公司
2024/11/02New drug · Class 1 SYHX1901片CXHL2401160 石药集团欧意药业有限公司
2024/11/02New drug · Class 2.1;2.4 盐酸(R)-氯胺酮注射液CXHL2401159 江苏豪森药业集团有限公司
2024/11/02New drug · Class 1 SYHX1901片CXHL2401158 石药集团欧意药业有限公司
2024/11/02New drug · Class 2.2 BN020827HCXHL2401157 山东百诺医药股份有限公司
2024/11/01Import · Class 2.2 注射用德曲妥珠单抗JXSL2400211 Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2024/11/01Import · Class 1 PIT565JXSL2400210 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/11/01Import · Class 3.1 13价肺炎球菌多糖结合疫苗JXSL2400209 Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd.
2024/11/01Import · Class 2.4 BMS-986165片JXHL2400262 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/11/01Import · Class 2.4 BMS-986165片JXHL2400261 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/11/01Import · Class 2.4 BMS-986165片JXHL2400260 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/11/01Generic · Class 3 钠钾镁钙注射用浓溶液CYHS2403726 河南上恒医药科技有限公司; 山东方明药业集团股份有限公司
2024/11/01Generic · Class 3 盐酸纳美芬注射液CYHS2403723 甘肃农垦药物碱厂有限公司; 山东威智百科药业有限公司
2024/11/01Generic · Class 3 劳拉西泮片CYHS2403722 北京益民药业有限公司
2024/11/01Generic · Class 3 黄体酮注射液CYHS2403721 重庆万霖生物医药科技有限公司; 河南科伦药业有限公司

72 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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